- Master's Degree
- Bachelor's Degree
- Design Controls
- Root Cause Analysis
- Risk Management
- Quality Systems
Careers that Change Lives
You will join an advanced team of mechanical, electrical and software engineers responsible for developing Medtronic’s next generation products and newest technologies in the rapidly advancing Gynecological Women’s Health market.
Impact patient outcomes. Come for a job, stay for a career
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
Surgical Innovations set the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.
Gynecological Women’s Health group is committed to increasing patient access, improving affordability, and expanding less invasive options for women around the world. We will become the leader in GYN by collaborating with the healthcare community, partnering in surgeon and patient education, driving product innovation and standardizing care in MIS and less invasive therapies. We aspire to become the most trusted women’s health company globally.
A day in the life
A Design Quality Engineer II in the Woburn, MA office is expected to collaborate and communicate effectively with our cross functional teams and uphold Tenet 3 of the Medtronic mission: To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service.
Provide Quality Engineering support to ensure the successful development of Medtronic GYN products and ongoing operational support.
Actively learn, and apply knowledge of Quality Systems, Design Controls, Risk Management, Statistics and Design for Reliability to positively influence development efforts, quality systems and processes, and ongoing contract manufacturing support as needed.
Ensure products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, customer requirements, and product specifications.
Apply statistical techniques to determine sample size for testing, to analyze data, to determine process capability, to complete Measurement Systems Analyses, etc. (i.e. T-test, Tolerance Analysis, Bayes Success Run/Weibel analysis, Capability Analysis, Design of Experiments/ANOVA)
Bachelor’s Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality
OR Master’s Degree Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.
Nice to Have
A Master’s Degree in Biomedical, Mechanical, Electrical, Software, or other related engineering field and/or 1 to 2 years of experience in Medical Devices
Applied understanding of industry standards and regulations including, but not limited to: ISO 13485, 21CFR820, European Medical Device Directives (MDD), European Medical Device Regulations (MDR), ISO 14971, IEC 60601 series, IEC 62366-1, IEC 62304.
Experience with any of the following software suites: Matlab, Minitab, SAS,
Experience applying Risk Management tools (Hazard Analysis, Risk Analysis, FMEA’s, Fault Tree Analysis, Use Error Analysis, etc.)
Experience applying root cause analysis tools (Fishbone charts, 5 Why’s, DMAIC, etc.)
Experience writing or guiding product requirements development*
Experience with gynecological medical devices
Experience with Mechatronics
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)